(88 days)
HemaPrompt is a gualac-based in-vilro slide method for the qualitative detection of occult blood in feces and gastric aspirate or vomitus by medical professionals only.
For fecal testing, it is a useful ald In the diagnosis of a number of gastrointestinal disorders, and is recommended for use in 1) routine physical examinations 2) routine hospital testing 3) screening for colorectal cancer or gastro-Intestinal bleeding from any other source.
For the testing of gastric contents it is used for the early detection of occult blood in conditions such as gastric trauma, gastric or duodenal ulceration, gastric cancer, esophageal varices, situations of likely exogenous or endogenous gastrills, leukemia, and hereditary telangiectasia. These conditions may be encountered in the emergency room, recovery room or intensive care.
The HemaPrompt slide, used with a buffered developer, is a guaiac based test for the detection of occult blood in both gastric and fecal samples. The test is not affected by low pH. When used with gastric specimens, it is free from interferences by normal therapeutic concentrations of iron, ranitidine, cimetidine and antacids.
When a gastric or fecal specimen containing blood is applied to the HemaPrompt test paper, hemoglobin from the lysed blood cells in the sample comes in contact with the guaiac in the paper. The developer, a buffered solution of alcohol and hydrogen peroxide, is applied by pulling the tab on the slide and creates a guaiac / peroxidase-like reaction in the presence of hemoglobin which in turn causes a blue coloration in the test paper. This test will turn blue in the presence of more than 2 mg Hb/ G stool and more than 200 mcg Hb/ ml gastric juice
Here's a breakdown of the acceptance criteria and study information for HemaPrompt, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Detection Limit) | Reported Device Performance (Fecal) | Reported Device Performance (Gastric) |
|---|---|---|
| Fecal: > 2 mg Hb/G stool | Reliably and definitely reacted at >= 2 mg Hb/G of stool within 60 seconds. | N/A |
| Gastric: > 200 mcg Hb/ml gastric juice | N/A | Reliably and definitely reacted at >= 200 mcg Hb/ml gastric juice within 60 seconds (for concentrations of 200 mcg/ml and greater, 100% positive reactions were observed). |
| Fecal: False Positive Rate for controlled diet |
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.